None listed
Conditions
Interventions
Others(health functional food) : Experimental (MI-Pro): Once a day, 1 stick per time, 12 weeks, oral intake with plenty of water (probiotics 1.0x10^10 CFU/day)
Control food (Placebo): Once a day, 1 st
Sponsors
Dong-A University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A persons aged 50 or older and 85 or younger 2) A person whose grip strength measurement of both hands falls below the age standard ? 50 years old and 59 years old or less: 42 kg or less for men and 25.1 kg or less for women ? 60 years old or older, 69 years old or younger: 38.5 kg or less for men and 24.1 kg or less for women ? 70 years old or older, 85 years old or younger: 33.2 kg or less for men and 20.9 kg or less for women 3) A person whose simple physical performance evaluation (SPPB) exceeds 9 points 4) A person who has agreed to participate in the human body application test before the commencement of the human body application test and has prepared an Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) A person who currently under treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous systems, psychotropic, infectious diseases and malignant tumors (except for skin tumors other than melanoma, those who have recovered from cancer after five years can participate) 2) A person who judged to be unable to exercise due to musculoskeletal diseases, neurological diseases, cognitive impairment, etc. 3) A person with a fragile hip fracture 4) A person who has a problem with eating Investigational food for human application test due to gastrointestinal disorders 5) A person who was taking drugs in neuropsychiatry due to psychiatric disorders (but depression that is intermittently administered or properly treated due to sleep disorders may participate in the examiner's judgment) 6) A person whose grip strength is less than 28 kg for men and less than 18 kg for women 7) A person who with a BMI of 30 kg/m^2 or higher 8) A person who systemic steroid preparations (cortisol, etc.) or hormone preparations (testosterone, estrogen, androgen, growth-related hormones, adrenocortical hormones, etc.) within 4 weeks of visit 1 (but statin preparations can be participated if they are being taken without change of dose for at least 6 months 9) A person who have used muscle strength improvement-related supplements (amino acids, creatines, etc.) or muscle strength improvement-related health functional foods (including calcium and vitamin D) within 2 weeks of visit 1 (but calcium and vitamin D can be participated if they have been administered without change of dose since 3 months ago) 10) A person who has taken drugs (muscle relaxants etc.) that may affect his or her muscles or received non-drug treatment within one week on the basis of visit 1 11) A person who has received non-drug treatment within one week on the basis of visit 1 12) A person who has received administered systemic antibiotics, systemic antimicrobials, or intestinal drug within 2 weeks of visit 1 13) A person who has received administered or intaked probiotics, prebiotics, fermented milk, or lactic acid bacteria products continuously (more than 4 times a week) within 2 weeks of visit 1 14) A person who has a history of alcohol abuse or is chronically consuming alcohol *Drinks alcohol equivalent to an average of 40 g or more (280 g/week) per day for men and 20 g or more (140 g/week) per day for women 15) A person who excessive smokers (20 or more per day) 16) A person who has participated in resistance exercises continuously (more than 3 days a week) within 3 months on the basis of visit 1 17) A person with an eGFR of less than 60 mL/min/1.73 m^2 18) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 19) Uncontrolled hypertension patients (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, and measurement criteria after stabilizing for 10 minutes in the test subjects) 20) Uncontrolled Diabetes Patients (HbA1c > 7.0%) 21) A person who TSH is less than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/Ml 22) A person who diagnosed with sarcopenia 23) A person who is pregnant or is lactating or has a pregnancy plan during the main human body application test period 24) A person who has participated in other interventional clinical trials (including human-applied trials) within thre
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| ASM/Height^2;ASM/Weight x 100;SMM (Skeletal Muscle Mass);MFR (Muscle-to-Fat Ratio);EQ-5D-3L (EuroQoL 5-Dimension descriptive system) ;Microbiome;Blood indicators (IGF-1, IL-6);Hamstring strength;Adverse Event;Clinical pathology test (Hematological/blood chemical test, urine test);Vital signs (Blood pressure, Pulse);Electrocardiogram test;Physical measurements (Weight) | — |
Primary
| Measure | Time frame |
|---|---|
| Quadriceps femoris muscle strength;Handgrip strength;SPPB (Short Physical Performance Battery) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeongho Han
Dong-A University
Outcome results
None listed